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Challenge
Create a disposable one-handed internal defibrillation system.
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Challenge
Pioneering cardiac surgeon, Dr. Hugo Vanermen – Aalst Hospital Belgium theorized a retractor that “swivels like a hip joint, and locks anywhere within its range of motion” could make minimally invasive cardiac surgery easier and safer. His concept would increase the surgical site thereby simplifying minimally invasive heart valve repair. USB Medical partnered with him to realize his vision.
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Process
Through design and electrical engineering analysis, USB developed electro-mechanical connectors allowing the company to mate with virtually all defibrillation systems on the market. This critical first step linked USB's PulseOne™ System with the market-share leaders in hospital defibrillator sales.
To make it happen, we rapidly engineered and prototyped multiple co-molded wire insert, Swiss and CNC machined connectors which met regulatory and key customer requirements. Through key suppliers, USB also tooled and managed the production ramp and developed all supply chain logistics. USB later developed a proprietary disposable paddle to extend our patent pending minimally invasive internal defibrillation product line.
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Process
USB observed Dr. Vanermen using existing retractors. Upon detailed analysis, we conferred with Dr. Vanermen regarding our conclusions and potential approaches. We then designed, engineered, and prototyped the instrument and accessories to realize his vision. Our solution includes the following patented features and benefits: Retractor heads that mechanically auto-center to evenly distribute pull force, reduce tissue damage, and accommodate patient's physiology. A high strength hinge at the distal end actuated by a control arm and knob at the proximal end. An adjustable open-walled hinge blade, enabling tissue manipulation while fully exposing the surgical site.
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Result
The PulseOne™ System is poised to become the standard for internal defibrillation.
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Result
USB's solution increases visibility of the mitral valve during minimally invasive procedures by 80%. Upon market entry, the HV Retractor gained rapid attention among top surgeons and industry leaders worldwide, for simplifying surgery, decreasing procedure times and improving overall patient outcomes.
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